On February 9, 2012, FDA released a new guidance document called, “Guidance For Sponsors, Investigators, and Institutional Review Boards – Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c).” The guidance is intended to help small businesses understand the new informed consent requirements described in 21 C.F.R. § 50.25(c), which requires that informed consent documents and processes for “applicable clinical trials,” initiated on or after March 7, 2012, include a specific statement that clinical trial information will be entered into the clinical trial registry databank maintained by the National Institutes of Health/National Library of Medicine. That statement is, “A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”

In the guidance, FDA clarifies that if an IRB has approved any informed consent documents for the applicable clinical trial before March 7, 2012, then the trial will be considered “initiated” prior to the compliance date, and the new statement will not be required in the informed consent documents. Guidance, p. 4. FDA also explains that any applicable clinical trial, including those conducted outside of the United States, must include the new statement in informed consent documents. Regarding waiver of documentation of informed consents, the agency affirms that, “the trial participant still provides consent and the statement is required during the oral presentation of the research and/or in the written statement regarding the research, if required by the IRB under 21 CFR § 56.109(d).” Guidance, p. 5. Finally, according to the guidance, if an informed consent document fails to properly include the statement, then the IRB should be notified and a revised consent form containing the statement should be provided to the IRB for review and approval.